Preoperative AnxietyNCT06648122
Association of Inflammatory Markers With Preoperative Anxiety and Agitation
An observational study of Preoperative Anxiety and Emergence Agitation, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety, Emergence Agitation
- What is being tested?
- laboratory results
- How many people
- 350 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2024to 30 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who will undergo surgery
Who may be able to join
- Pediatric patients aged 5-12 years
- ASA I-II groups
- Pediatric patients who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery.
Who cannot join
- Those with genetic disorders affecting brain development
- Those diagnosed with psychiatric and neurological diseases
- Patients with attention deficit, mental retardation
- Patients with hematological and/or immune system disorders
- Patients who will undergo surgery in neurosurgery and cardiovascular surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University, Faculty of Medicine, Department of Anesthesiology
Adana, Turkey, 01380
About this study
Official title: Association of Preoperative Inflammatory Markers With Preoperative Anxiety and Emergence Agitation in Children
This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium
Read the detailed description
Inclusion criteria for the study: Pediatric patients aged 5-12 years, in the ASA I-II groups, who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery. Exclusion criteria for the study can be listed as follows: Those with genetic diseases affecting brain development, those diagnosed with psychiatric and neurological diseases, patients with attention deficit, mental retardation, those with hematological and/or immune system disorders, patients who will undergo surgery in neurosurgery and cardiovascular surgery.
During the preoperative visit, parents and children will be informed and their written and verbal consent will be obtained. Patients will be taken to the preoperative waiting room and hemogram values and ratios (WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII) will be recorded from medical records. Demographic data (including age, gender, BMI, ASA score, fasting time, previous surgery, hospitalization status, the use of steroid), preoperative anxiety score (to be assessed with m-YPAS Turkish version), parental accompaniment, anxiety score of the parent (to be assessed with Likert scale), preoperative medication application, medications used in anesthesia, airway device, surgery and anesthesia durations will be recorded. The PAED score will be used for delirium agitation and all values will be recorded during the first 30 min. Pain scores (FLACC and VAS) will be recorded in the case report form.
- Conditions
- Preoperative Anxiety, Emergence Agitation
- Being tested
- laboratory results
- Keywords
- Children, Preoperative anxiety, Emergence agitation, Inflammation
- Medical subject headings
- Emergence Delirium, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory resultsOther
evaluation of laboratory results (hemogram results:WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII)
What is being measured
The primary outcome is the main question the study is designed to answer.
PAED score
Emergence agitation will be evaluated in the postoperative unit with PAED scoring. PAED (Paediatric Emergence Delirium) parameters includes child makes eye contact with caregiver, child's actions are purposeful, child is aware of his/her surroundings, child is restless, child is inconsolable.All items are scored on a 0-4 point scale as occurring not at all, just a little, quite a bit, very much, If the sum of the five-parameter scale scores is ≥ 10, emergence agitation can be mentioned.
Measured: first 30 minutes in the postoperative unit.
Secondary outcomes (2)
mYPAS score
The Turkish version of the mYPAS (modified yale properative anxiety score) (Scores: min:23.3-max:100) scoring system will be used to assess preoperative anxiety in the preoperative unit. This score to be applied to each patient includes five categories and is applied observationally.
The calculation of this score is as follows: (activity / 4 + emotional expression / 4 + the state of arousal / 4 + use of parents / 4 + vocalization / 6) × 100 / 5. Patients with m-YPAS≥40 will be considered anxious.
Measured: 15 minutes before surgery in the preoperative unit
Demographic data
Age (year), gender, weight (kg) height (cm), BMI (kg/m2), previous surgery, fasting time, hospitalization state, parental accompaniment, score of the parent anxiety (to be assessed with Likert scale), preoperative medication application, drugs used in anesthesia, surgery and anesthesia durations, pain scores will be assessed.
Measured: until the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start21 Oct 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Hatipoglu, MD, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648122
- Sponsor's protocol ID
- 09/2024;5
- Status last verified
- Jul 2025
- First submitted
- 8 Oct 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Soylu NMA, Hatipoglu Z, Gulec E, Turktan M, Sadikoglu N, Arslan YK, Ozcengiz D. Association of Preoperative Inflammatory Markers With Preoperative Anxiety and Emergence Agitation in Children. Paediatr Anaesth. 2026 Sep;36(9):1132-1142. doi: 10.1002/pan.70246. Epub 2026 Jun 18.
PubMed 42311198
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Preoperative Inflammatory Markers With Preoperative Anxiety and Emergence Agitation in Children
- ClinicalTrials.gov ID
- NCT06648122
- Acronym / sponsor ID
- 09/2024;5
- Conditions
- Preoperative Anxiety, Emergence Agitation
- Keywords
- Children, Preoperative anxiety, Emergence agitation, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium
Detailed description
Inclusion criteria for the study: Pediatric patients aged 5-12 years, in the ASA I-II groups, who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery. Exclusion criteria for the study can be listed as follows: Those with genetic diseases affecting brain development, those diagnosed with psychiatric and neurological diseases, patients with attention deficit, mental retardation, those with hematological and/or immune system disorders, patients who will undergo surgery in neurosurgery and cardiovascular surgery.
During the preoperative visit, parents and children will be informed and their written and verbal consent will be obtained. Patients will be taken to the preoperative waiting room and hemogram values and ratios (WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII) will be recorded from medical records. Demographic data (including age, gender, BMI, ASA score, fasting time, previous surgery, hospitalization status, the use of steroid), preoperative anxiety score (to be assessed with m-YPAS Turkish version), parental accompaniment, anxiety score of the parent (to be assessed with Likert scale), preoperative medication application, medications used in anesthesia, airway device, surgery and anesthesia durations will be recorded. The PAED score will be used for delirium agitation and all values will be recorded during the first 30 min. Pain scores (FLACC and VAS) will be recorded in the case report form.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who will undergo surgery
Key inclusion criteria (3 listed)
- Pediatric patients aged 5-12 years
- ASA I-II groups
- Pediatric patients who will undergo surgery in ophthalmology, urological surgery, ENT surgery, pediatric surgery, orthopedic and plastic surgery.
Key exclusion criteria (5 listed)
- Those with genetic disorders affecting brain development
- Those diagnosed with psychiatric and neurological diseases
- Patients with attention deficit, mental retardation
- Patients with hematological and/or immune system disorders
- Patients who will undergo surgery in neurosurgery and cardiovascular surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory resultsevaluation of laboratory results (hemogram results:WBC, RBC, Hematocrit, Monocyte count, Neutrophil count, Lymphocyte count, Platelet count, PDW, MPV, MLR, NLR, NMR, PLR, PMR, PNR, PWR, SII) | Other | – |
Primary outcome
PAED score
Time frame: first 30 minutes in the postoperative unit.
Emergence agitation will be evaluated in the postoperative unit with PAED scoring. PAED (Paediatric Emergence Delirium) parameters includes child makes eye contact with caregiver, child's actions are purposeful, child is aware of his/her surroundings, child is restless, child is inconsolable.All items are scored on a 0-4 point scale as occurring not at all, just a little, quite a bit, very much, If the sum of the five-parameter scale scores is ≥ 10, emergence agitation can be mentioned.
2 secondary outcomes
mYPAS score
Time frame: 15 minutes before surgery in the preoperative unit
Demographic data
Time frame: until the completion of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Derived from this study: PubMed 42311198Soylu NMA, Hatipoglu Z, Gulec E, Turktan M, Sadikoglu N, Arslan YK, Ozcengiz D. Association of Preoperative Inflammatory Markers With Preoperative Anxiety and Emergence Agitation in Children. Paediatr Anaesth. 2026 Sep;36(9):1132-1142. doi: 10.1002/pan.70246. Epub 2026 Jun 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Anxiety and Emergence Agitation, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAED score (time frame: first 30 minutes in the postoperative unit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.